Trial Outcomes & Findings for Assessment of Switching From Salmeterol/Fluticasone to Indacaterol/Glycopyrronium in a symtomaticCOPD Patient Cohort (NCT NCT02516592)
NCT ID: NCT02516592
Last Updated: 2019-03-21
Results Overview
Pulmonary function assessments were performed using centralized spirometry according to international standards. Mean trough pre-dose FEV1 at Week 12 is defined as the average of the measurements taken -45min and -15min pre study medication dose in the clinic after 12 weeks of treatment (Day 84). The baseline measurement is defined as the average of the scheduled FEV1 values prior to first intake of randomized study drug at Day 1 (Visit 2).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
500 participants
Primary outcome timeframe
Baseline, week 12
Results posted on
2019-03-21
Participant Flow
A total of 502 patients were randomized, of which 498 patients were included in the Full Analysis Set (FAS)
Participant milestones
| Measure |
QVA149 110/50 Micrograms
QVA149 110/50 micrograms o.d. Capsules for inhalation
|
Salmeterol/Fluticasone 50/500 Micrograms
salmeterol/fluticasone 50/500 micrograms b.i.d. Dry inhalation powder
|
|---|---|---|
|
Overall Study
STARTED
|
251
|
251
|
|
Overall Study
Full Analysis Set
|
248
|
250
|
|
Overall Study
COMPLETED
|
235
|
238
|
|
Overall Study
NOT COMPLETED
|
16
|
13
|
Reasons for withdrawal
| Measure |
QVA149 110/50 Micrograms
QVA149 110/50 micrograms o.d. Capsules for inhalation
|
Salmeterol/Fluticasone 50/500 Micrograms
salmeterol/fluticasone 50/500 micrograms b.i.d. Dry inhalation powder
|
|---|---|---|
|
Overall Study
Patient withdrew consent
|
5
|
2
|
|
Overall Study
Protocol deviation
|
4
|
4
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
|
Overall Study
Patient/guardian decision
|
2
|
1
|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Abnormal test procedure result
|
1
|
0
|
|
Overall Study
Death
|
1
|
1
|
Baseline Characteristics
The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to.
Baseline characteristics by cohort
| Measure |
QVA149 110/50 Micrograms
n=251 Participants
QVA149 110/50 micrograms o.d. Capsules for inhalation
|
Salmeterol/Fluticasone 50/500 Micrograms
n=251 Participants
salmeterol/fluticasone 50/500 micrograms b.i.d. Dry inhalation powder
|
Total
n=502 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 Years
STANDARD_DEVIATION 9.14 • n=248 Participants • The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to.
|
65.1 Years
STANDARD_DEVIATION 8.44 • n=250 Participants • The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to.
|
65 Years
STANDARD_DEVIATION 8.79 • n=498 Participants • The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to.
|
|
Sex: Female, Male
Female
|
28 Participants
n=248 Participants • The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to.
|
26 Participants
n=250 Participants • The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to.
|
54 Participants
n=498 Participants • The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to.
|
|
Sex: Female, Male
Male
|
220 Participants
n=248 Participants • The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to.
|
224 Participants
n=250 Participants • The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to.
|
444 Participants
n=498 Participants • The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=248 Participants • The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to
|
0 Participants
n=250 Participants • The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to
|
0 Participants
n=498 Participants • The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to
|
|
Race (NIH/OMB)
Asian
|
115 Participants
n=248 Participants • The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to
|
118 Participants
n=250 Participants • The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to
|
233 Participants
n=498 Participants • The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=248 Participants • The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to
|
0 Participants
n=250 Participants • The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to
|
0 Participants
n=498 Participants • The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=248 Participants • The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to
|
0 Participants
n=250 Participants • The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to
|
2 Participants
n=498 Participants • The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to
|
|
Race (NIH/OMB)
White
|
123 Participants
n=248 Participants • The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to
|
126 Participants
n=250 Participants • The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to
|
249 Participants
n=498 Participants • The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=248 Participants • The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to
|
0 Participants
n=250 Participants • The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to
|
0 Participants
n=498 Participants • The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=248 Participants • The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to
|
6 Participants
n=250 Participants • The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to
|
14 Participants
n=498 Participants • The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to
|
PRIMARY outcome
Timeframe: Baseline, week 12Population: The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to
Pulmonary function assessments were performed using centralized spirometry according to international standards. Mean trough pre-dose FEV1 at Week 12 is defined as the average of the measurements taken -45min and -15min pre study medication dose in the clinic after 12 weeks of treatment (Day 84). The baseline measurement is defined as the average of the scheduled FEV1 values prior to first intake of randomized study drug at Day 1 (Visit 2).
Outcome measures
| Measure |
QVA149 110/50 Micrograms
n=248 Participants
QVA149 110/50 micrograms o.d. Capsules for inhalation
|
Salmeterol/Fluticasone 50/500 Micrograms
n=250 Participants
salmeterol/fluticasone 50/500 micrograms b.i.d. Dry inhalation powder
|
|---|---|---|
|
Change From Baseline in Trough Pre-dose FEV1 in Both Arms
|
0.036 Liters
Standard Error 0.0151
|
-0.009 Liters
Standard Error 0.0152
|
SECONDARY outcome
Timeframe: Baseline, week 12Population: The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to.
Transition Dyspnea Index (TDI) is an instrument used to assess a participant's level of dyspnea. The TDI focal score have three domains: functional impairment, magnitude of task and magnitude of effort. TDI domains were rated from -3 (major deterioration) to 3 (major improvement) and rates summed for transition focal score ranged from -9 to 9; negative scores indicate deterioration. A TDI focal score of ≥1 was defined as a clinically important improvement from baseline.
Outcome measures
| Measure |
QVA149 110/50 Micrograms
n=248 Participants
QVA149 110/50 micrograms o.d. Capsules for inhalation
|
Salmeterol/Fluticasone 50/500 Micrograms
n=250 Participants
salmeterol/fluticasone 50/500 micrograms b.i.d. Dry inhalation powder
|
|---|---|---|
|
Transitional Dyspnea Index (TDI) Focal Score
|
3.24 Score on a scale
Standard Error 0.405
|
2.79 Score on a scale
Standard Error 0.399
|
SECONDARY outcome
Timeframe: week 12Population: The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to
Pulmonary function assessments were performed using centralized spirometry according to international standards. FVC wil follow the same analysis as for FEV1
Outcome measures
| Measure |
QVA149 110/50 Micrograms
n=248 Participants
QVA149 110/50 micrograms o.d. Capsules for inhalation
|
Salmeterol/Fluticasone 50/500 Micrograms
n=250 Participants
salmeterol/fluticasone 50/500 micrograms b.i.d. Dry inhalation powder
|
|---|---|---|
|
Change From Baseline in FVC (Forced Vital Capacity)
|
0.073 Liters
Standard Error 0.0248
|
-0.028 Liters
Standard Error 0.0250
|
SECONDARY outcome
Timeframe: week 12Population: The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to
The participants will record their COPD symptoms in this test before every clinic visit, this will include : cough, phlegm, chest tightness, breathlessness, limitation in activities, energy, soundly sleep, etc. A higher score indicates a worse health status. The result is immediately available without the need for any calculation, apart from summing the scores on individual items. Scores of 0 - 10 represent mild, 11 - 20 represent moderate, 21 - 30 represent severe and 31 - 40 represent very severe clinical impact of COPD upon the patient.
Outcome measures
| Measure |
QVA149 110/50 Micrograms
n=248 Participants
QVA149 110/50 micrograms o.d. Capsules for inhalation
|
Salmeterol/Fluticasone 50/500 Micrograms
n=250 Participants
salmeterol/fluticasone 50/500 micrograms b.i.d. Dry inhalation powder
|
|---|---|---|
|
Change From Baseline in Total Symptom Score- CAT (COPD Assessment Test)
|
13.4 Score on a scale
Standard Error 0.48
|
13.8 Score on a scale
Standard Error 0.47
|
SECONDARY outcome
Timeframe: over 12 weeksPopulation: The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to
Use of rescue medication (number of puffs taken in the previous 12 hours) is recorded morning and evening, by the patient, in a paper diary. A negative change from baseline indicates an improvement.
Outcome measures
| Measure |
QVA149 110/50 Micrograms
n=248 Participants
QVA149 110/50 micrograms o.d. Capsules for inhalation
|
Salmeterol/Fluticasone 50/500 Micrograms
n=250 Participants
salmeterol/fluticasone 50/500 micrograms b.i.d. Dry inhalation powder
|
|---|---|---|
|
Change From Baseline in Mean Daily Use of Rescue Medication
|
1.05 Number of puffs
Standard Error 0.132
|
1.09 Number of puffs
Standard Error 0.130
|
Adverse Events
QVA149
Serious events: 9 serious events
Other events: 39 other events
Deaths: 1 deaths
Salm/Flut
Serious events: 9 serious events
Other events: 50 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
QVA149
n=248 participants at risk
QVA149 110/50 micrograms o.d. Capsules for inhalation
|
Salm/Flut
n=250 participants at risk
salmeterol/fluticasone 50/500 micrograms b.i.d. Dry inhalation powder
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/248 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
0.40%
1/250 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
|
Cardiac disorders
Atrial fibrillation
|
0.40%
1/248 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
0.00%
0/250 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
|
Cardiac disorders
Bundle branch block right
|
0.40%
1/248 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
0.00%
0/250 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
|
Congenital, familial and genetic disorders
Thalassaemia beta
|
0.40%
1/248 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
0.00%
0/250 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
|
Eye disorders
Cataract
|
0.00%
0/248 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
0.40%
1/250 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
|
Eye disorders
Entropion
|
0.00%
0/248 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
0.40%
1/250 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/248 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
0.40%
1/250 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/248 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
0.40%
1/250 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.40%
1/248 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
0.00%
0/250 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
|
General disorders
Sudden death
|
0.40%
1/248 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
0.00%
0/250 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/248 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
0.40%
1/250 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
|
Hepatobiliary disorders
Hydrocholecystis
|
0.00%
0/248 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
0.40%
1/250 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/248 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
0.40%
1/250 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
|
Infections and infestations
Pneumonia
|
0.00%
0/248 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
0.40%
1/250 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.40%
1/248 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
0.00%
0/250 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/248 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
0.40%
1/250 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.40%
1/248 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
0.00%
0/250 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma metastatic
|
0.40%
1/248 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
0.00%
0/250 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/248 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
0.40%
1/250 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
|
Nervous system disorders
Cerebral infarction
|
0.40%
1/248 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
0.00%
0/250 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
|
Nervous system disorders
Ischaemic stroke
|
0.40%
1/248 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
0.00%
0/250 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/248 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
0.40%
1/250 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.2%
3/248 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
1.2%
3/250 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.40%
1/248 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
0.00%
0/250 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
|
Vascular disorders
Penetrating aortic ulcer
|
0.40%
1/248 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
0.00%
0/250 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
Other adverse events
| Measure |
QVA149
n=248 participants at risk
QVA149 110/50 micrograms o.d. Capsules for inhalation
|
Salm/Flut
n=250 participants at risk
salmeterol/fluticasone 50/500 micrograms b.i.d. Dry inhalation powder
|
|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/248 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
1.2%
3/250 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
|
Infections and infestations
Upper respiratory tract infection
|
2.4%
6/248 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
2.0%
5/250 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.2%
3/248 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
1.6%
4/250 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
9.7%
24/248 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
12.4%
31/250 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
6/248 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
1.2%
3/250 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.81%
2/248 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
2.4%
6/250 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/248 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
1.2%
3/250 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
|
Vascular disorders
Hypertension
|
2.0%
5/248 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
0.80%
2/250 • All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER